PRedictive Value of Multiparametric Dynamic WB 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1 (PROFIL-1)

December 13, 2024 updated by: University Hospital, Brest

PRedictive Value of Multiparametric Dynamic Whole-body 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1 Study

Lung cancer is the leading cause of cancer deaths worldwide. Revolution of chemo-immunotherapy (CT-IO) in first-line of metastatic non-small-cell lung cancers (NSCLC) without actionable genomic alterations (AGAs) has dramatically improved prognosis, providing long response to a subset of patients. Because of a highly heterogeneous disease, majority of patients do not show long term benefit. Long axial field of view positron emission tomography (LAFOV-PET) scanner is a new emerging system allowing dynamic whole-body imaging with higher sensitivity, representing unique opportunity for oncological applications. The aim of this study is to determine if LAFOV-PET imaging biomarkers could early predict response to CT-IO in NSCLC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung cancer is the leading cause of cancer deaths worldwide. Revolution of chemo-immunotherapy (CT-IO) in first-line of metastatic non-small-cell lung cancers (NSCLC) without actionable genomic alterations (AGAs) has dramatically improved prognosis, providing long response to a subset of patients. Because of a highly heterogeneous disease, majority of patients do not show long term benefit. Long axial field of view positron emission tomography (LAFOV-PET) scanner is a new emerging system allowing dynamic whole-body imaging with higher sensitivity, representing unique opportunity for oncological applications. The aim of this study is to determine if LAFOV-PET imaging biomarkers could early predict response to CT-IO in NSCLC.

PROFIL-1 is a multicentre, single-arm, prospective non-interventional pilot study investigating the predictive value of multiparametric 18F-fluoro-deoxyglucose whole-body dynamic PET imaging on a LAFOV system for first-line CT-IO efficacy in advanced NSCLC, with a planned enrolment of 120 patients at 2 French sites. Adult patients with treatment-naïve advanced non-squamous or squamous NSCLC without AGAs and eligible for first-line CT-IO will be recruited for PROFIL-1. Patients will undergo LAFOV-PET before and after CT-IO induction. The primary objective is to evaluate predictive performance of a whole-body multiparametric analysis (radiomics and dynamics) in LAFOV-PET on CT-IO efficacy based on progression-free survival (PFS) per RECIST v1.1 by investigators. Secondary endpoints included correlations between imaging parameters and clinico-pathological characteristics, comparison between direct Patlak and indirect Patlak methods to determine dynamic parameters such as Ki (the net influx rate) and distribution volume (DV), number of tumor lesions and signal-to-noise ratio, objective response rate (ORR), overall survival (OS) and safety.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Brest, France, 29609
      • Morlaix, France, 29600
        • Morlaix Hospital Center
        • Contact:
        • Contact:
          • Karim AMRANE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with unresectable locally advanced non-irradiable or metastatic NSCLC, whose files are presented to the thoracic oncology Multidisciplinary Team at the Brest University Hospital and the Morlaix University Hospital, and for whom chemo-immunotherapy is indicated as 1st line treatment.

Description

Inclusion Criteria:

  • Adult patients ≥ 18 years
  • With advanced, non-operable, non-radiatable or metastatic NSCLC
  • Treatment-naïve patients
  • Eligible for first-line chemo-immunotherapy (anti-PD-1)
  • Written Non-objection
  • Eligible for LAFOV FDG-PET less than 21 days before initiation of treatment

Exclusion Criteria:

  • Minor patients <18 years
  • Oncogenic addiction targetable in 1st line: EGFR, ALK, ROS1, RET
  • Pregnancy or breast-feeding
  • Other histology than NSCLC
  • Ineligible for first-line chemo-immunotherapy
  • PET-FDG Scan contraindications
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year Progression-Free Survival
Time Frame: From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.
The primary endpoint is 1-year Progression-Free Survival (PFS) rate. PFS is defined as the time from chemo-immunotherapy initiation to the date of the first documented event of tumor progression or death in the absence of disease progression, whichever came first, assessed up to 100 months.
From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Ki images
Time Frame: From baseline PET/CT before chemo immunotherapy in ml/min/100 g
Measurement of Ki images PET/CT parameters based on direct and indirect Patlak reconstruction methods with PBIF or IDIF in LAFOV-PET from baseline PET/CT before chemo immunotherapy
From baseline PET/CT before chemo immunotherapy in ml/min/100 g
Measurement of distribution volume
Time Frame: From baseline PET/CT before chemo immunotherapy in L/kg
Measurement of distribution volume dynamic PET/CT parameter based on direct and indirect Patlak reconstruction methods with PBIF or IDIF in LAFOV-PET from baseline PET/CT before chemo immunotherapy
From baseline PET/CT before chemo immunotherapy in L/kg
Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters
Time Frame: From baseline PET/CT before chemo immunotherapy
Correlation analyses between quantitative dynamic and radiomic PET derived parameters and clinico-histopathological parameters (clinical, biology, histology, genomic).
From baseline PET/CT before chemo immunotherapy
Contrast-to-noise ratio (CNR)
Time Frame: From baseline LAFOV PET/CT
Contrast-to-noise ratio (CNR) (indicating the image quality in the lesion)
From baseline LAFOV PET/CT
Target-to-background ratio (TBR)
Time Frame: From baseline LAFOV PET/CT
Target-to-background ratio (TBR), defined as the ratio of the lesions' SUVmax and the SUVmean of healthy liver tissue (background) determined for each reconstruction algorithm
From baseline LAFOV PET/CT
Objective response rate (ORR)
Time Frame: From baseline LAFOV PET to end of 1 year of treatment
Objective response rate (ORR), defined as the proportion of patients experiencing an objective response (either complete response [CR] or partial response [PR]) as best response to CT-IO according to RECIST 1.1 criteria
From baseline LAFOV PET to end of 1 year of treatment
Metabolic response rate (MRR)
Time Frame: From baseline LAFOV PET to end of 1 year of treatment
Metabolic response rate (MRR), defined as the proportion of patients experiencing a metabolic response (either complete metabolic response [CMR] or partial metabolic response [PMR]) as best response to CT-IO according to Positron Emission Tomography Response Criteria in Solid Tumors version 1.0 (PERCIST v1.0)
From baseline LAFOV PET to end of 1 year of treatment
Overall Survival
Time Frame: From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months
Overall Survival, defined as the time from chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months
From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months
Safety
Time Frame: From baseline LAFOV PET to end of 1 year of treatment
Safety and tolerability according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.; Patient reported outcomes according to EQ-5D-5L and EORTC QLQ-C30 (baseline, 3 months, 6 months, 12 months).
From baseline LAFOV PET to end of 1 year of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Margaux GEIER, University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

November 2, 2026

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC24.0049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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